US20030125730A1 - Flexible device for ablation of biological tissue - Google Patents

Abstract

An ablation system incorporating an enhanced deflectable distal portion, is provided. The system includes an elongated tubular member having a deflectable distal portion adapted to assume a specific predetermined or predefined shape when deployed. The predetermined shape allows for the creation of a desired uniform energy emission pattern with respect to a target tissue, such that energy may be directed toward the target tissue independent of an approach orientation of the ablation system. The energy pattern results in the creation of a desired tissue ablation. The ablation system may further comprise a steering system which aides in directing the distal portion toward a target tissue site. The steering system may alternatively be incorporated into a separate guiding catheter as part of the ablation system.

Description

BACKGROUND OF THE INVENTION
• 1. Field of Invention[0001]
• The present invention relates generally to catheter systems used in diagnosis and treatment of various body tissues and, more specifically, to ablation systems for ablating cardiac tissue in the treatment of electrophysiological diseases.[0002]
• 2. Description of the Related Art[0003]
• As is well know, catheters provide medical professionals access to various interior regions of the human body in a minimally invasive manner. In such a way, catheters are tremendous medical tools in support of diagnosis and treatment of different tissues of the body. Catheters allow such professionals to place one or more medical instruments, pharmacological agents or other matter at a target tissue site. For example, in cardiac procedures in support of diagnosis and treatment of atrial fibrillation, catheters provide access to various chambers of the heart, carrying ablation devices which translate therein to such sites for ablation of specific cardiac tissue associated with atrial fibrillation.[0004]
• Ablation of tissue, cardiac tissue for example, is typically directly related to the orientation of the ablation element, from which energy sufficient to ablate biological tissue is emitted, with respect to a target tissue site. For such procedures, precise control of the ablation device is desirable to ensure proper placement of the ablation element utilized in creation of one or more desired lesions. As an electrophysiologist, or other medical professional, manipulates the proximal end of the catheter system, the distal end of the catheter must be responsive to such movement in a very predetermined, smooth-flowing and proportional way.[0005]
• Additionally, the orientation of the ablation device, from which ablative energy is emitted and directed toward the target tissue, differs with the modality utilized for the procedure. For example, with tip electrode RF based devices, the tip must be properly placed in direct contact with the target tissue. For creation of numerous intermediate lesions along a desired lesion path, the tip electrode must be moved across the target tissue surface in a controlled fashion, which is often difficult due to inconsistencies of the tissue surface. Under certain conditions, the tip may act to impede movement across the surface of the target tissue, causing the tip to erratically jump or skip across the tissue in an undesirable way.[0006]
• For example, for the treatment of atrial flutter, it is often desirable to ablate the isthmus which lies between the inferior vena cava and the tricuspid valve. The contour of this tissue, while generally curvilinear, is irregular and inconsistent, comprising various peaks and valleys, which differ from individual to individual. Ablating tissue in this region often requires the precise and controlled placement of the distal tip of the ablation device. Because of the curvilinear nature of the isthmus, it has been found to be difficult to lay down a straight long linear ablation element to ablate this area. This task is complicated by the fact that the steering or guiding system of the ablation system typically directly impacts the approach and orientation of the tip upon the tissue, which further impairs the ability of the system to transmit sufficient ablative energy for proper tissue ablation. Furthermore, due to the desired depth of the ablation required at this location, proper placement of the ablation device is critical to the creation of a desired long continuous deep lesion therein.[0007]
• Proper placement of an ablation device is also exasperated by the fact that some ablative energy technologies require energy transmission conduits which are bulky, or otherwise constructed from materials less flexible, making the distal portion of the catheter difficult to properly position. For example, distal portions of optical fiber or microwave based ablation systems, or catheter systems comprising an endoscopic device, may be more difficult to maneuver due to the lack of flexibility in the transmission mediums utilized therein. As should be readily apparent, when the distal portion of an ablation catheter system is not properly positioned, ablative energy is not properly directed and applied to the target tissue, resulting in poor lesion formation. It is therefore essential that the ablative device be able to be manipulated and sufficiently controlled to be properly positioned to transfer the requisite energy to ablate biological tissue and create a desired lesion therein.[0008]
SUMMARY OF THE INVENTION
• Accordingly, it is a general object of the present invention to provide an ablation system which resolves the above-identified problems. Another object of the present invention is to provide an ablation system which ensures proper placement of an ablation device upon a target tissue to be ablated. Yet another object of the present invention is to provide an ablation system incorporating a deflectable ablative device which can emit a relatively uniform energy pattern therefrom. Another object of the present invention is to provide an ablation system to ablate tissue, forming a lesion therein which is substantially independent of an azimuth or approach angle. Still another object of the present invention is to provide an ablation system to easily and effectively ablate the isthmus between the inferior vena cava and the tricuspid valve without the need for a precise deflection system. Yet another object of the present invention is to provide a catheter system which ensures proper placement of an ablation device proximate a target tissue site during creation of a long continuous lesion.[0009]
• These and other objects are achieved through systems disclosed herein. More specifically, a system for ablating a selected portion of biological tissue at a target tissue site is provided. The system is particularly suitable to ablate cardiac tissue, as well as other soft tissues of the body, and includes a tubular member having a distal end including an ablative device which, in turn, includes one or more ablation elements adapted to emit ablative energy therefrom, and a steering system operably attached to a proximal section. The distal end of the tubular member is configured to be deflected into a predetermined geometric shape wherefrom a relatively uniform energy pattern is emitted, such that tissue ablation can occur substantially independent from an approach angle defined between the tubular member and the target tissue surface. In this way, for example, with a substantially side-firing ablation device one could bend or otherwise deflect the ablation device into a specific shape to obtain a uniform energy distribution about the distal end of the ablation device.[0010]
• In one embodiment, the ablation device includes at least one ablation element adapted to emit ablative energy therefrom. The ablation device is configured to engage tissue from one of many approach angles while maintaining proper ablative energy transfer to the tissue resulting in tissue ablation and the creation of one or more desired lesions.[0011]
• In another embodiment, the ablation device includes at least one flexible ablation element adapted to emit ablative energy therefrom. The at least one ablation element is configured to deflect along with the tubular member. Alternatively, the ablation device may include at least one ablation element having a geometric configuration which allows deflection of the distal end of the ablation device.[0012]
• In still another embodiment, the ablation device may also include a shielding means adapted to be opaque with respect to the corresponding ablative energy utilized, protecting tissues surrounding a target tissue site from the ablative energy. Additionally, the shielding means may be configured to reflect at least a portion of the ablative energy toward the target tissue site to facilitate or encourage tissue ablation and lesion formation.[0013]
• In still another embodiment, the tubular member of the ablation device translates within a tubular guiding member, the distal portion of the ablation device is adapted to include a preformed shape. As the ablation device emerges from the distal opening of the guiding member, the distal end assumes its preformed curvilinear shape. The preformed shape may be selected to facilitate the emission of a uniform energy pattern therefrom.[0014]
• In another embodiment, the ablation device is a catheter system wherein the tubular member is elongated to facilitate entry into a patient's vascular system and advancement to a target tissue site, a cardiac muscle site for example.[0015]
• The ablative energy is preferably electromagnetic energy in the microwave range. However, other suitable tissue ablation energies include, but are not limited to, cryogenic, ultrasonic, laser, chemical and radiofrequency.[0016]
• In yet another embodiment, the ablation device is a microwave antenna assembly which includes an antenna configured to emit microwave ablative energy. The ablation device may also include a shielding means coupled to the antenna assembly. The shielding means may be adapted to substantially shield a surrounding area of the antenna from the electromagnetic field radially generated therefrom while permitting a majority of the field to be directed generally in a predetermined direction toward the target tissue site. Alternatively, the shielding means, in another embodiment, may be adapted to absorb the electromagnetic energy transmitted therefrom protecting surrounding tissues. The ablation device may further include an insulator which functions to hold the shielding means and antenna in fixed relationship with respect to each other and a target tissue site, further controlling the ablative characteristics of the ablation device.[0017]
• In yet another embodiment, the steering system is part of an elongated guiding member having at least one lumen passing therethrough, the tubular member of the catheter translating therein.[0018]
• In another aspect of the present invention, a method for treatment of a Heart includes entering the ablative device into a patient's vasculature; guiding the distal end of the ablation device into a chamber of the patient's heart; manipulating the ablation device until the distal end is proximate a target tissue site; applying ablative energy from an energy source to the ablation device.[0019]
• In one embodiment, the manipulating is performed by incrementally advancing the ablative device along a plurality of positions along an ablation path to produce a substantially continuous lesion.[0020]
• In another embodiment, the step of manipulating is performed by incrementally sliding, or otherwise moving, the ablative device along a predefined ablation path to produce a long and substantially continuous lesion.[0021]
• In yet another embodiment, the step of sliding includes the step of positioning the ablative device in an overlapping arrangement with respect to prior ablation sites along the ablation path.[0022]
• Other objects and attainments together with a fuller understanding of the invention will become apparent and appreciated by referring to the following description and claims taken in conjunction with the accompanying drawings.[0023]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A is a side view of an ablation system.[0024]
• FIG. 1B is a side view of an ablation system including a flexible distal portion in accordance with the present invention.[0025]
• FIG. 2A-E are side views of an ablation system being deployed, in accordance with the present invention.[0026]
• FIGS.[0027]3A-C are side views of an alternative embodiment of an ablation system, in accordance with the present invention.
• FIG. 4A is a side view of a first embodiment of an ablation system in accordance with the present invention.[0028]
• FIG. 4B is an end view of the ablation system of FIG. 4A.[0029]
• FIG. 5A is a side view of another embodiment of an ablation system in accordance with the present invention.[0030]
• FIG. 5B is an end view of the ablation system of FIG. 4A.[0031]
• FIG. 6A is a side view of the ablation system of FIG. 5A shown with the distal end deflected to a first position.[0032]
• FIG. 6B is a side view of an ablation system incorporating an alternative ablation device, in accordance with the present invention.[0033]
DETAILED DESCRIPTION OF THE INVENTION
• While the present invention will be described with reference to a few specific embodiments, the description is illustrative of the invention and is not to be construed as limiting the invention. Various modifications to the present invention can be made to the preferred embodiments by those skilled in the art without departing from the true spirit and scope of the invention as defined by the appended claims.[0034]
• Turning to FIG. 1A, a[0035]catheter20 known in the art will be discussed. More specifically, FIG. 1A depictscatheter20 advanced from a point proximate to the femoral vein (not shown), through the inferior vena cava14 (IVC), and into theright atrium16, adistal tip26 ofcatheter20 engagingcardiac tissue10, between theIVC14 andtricuspid valve12. For purposes of clarity, the depiction of the cardiac structure has been simplified.
• The[0036]catheter20 comprises a long tubular member22 having a proximal portion (not shown) anddistal portion24, the proximal portion operably attached to a handle portion (not shown). Thedistal portion24 includes, or otherwise incorporates, anablation device30 including one or more ablation elements. The one or more ablation elements are arranged and configured to emit ablative energy in a direction generally away from an emission surface of thecatheter20 body, a portion of the radiating energy pattern generally designated by the arrows E and the emission surface corresponding to the outer catheter surface from which the energy is emitted, directly or indirectly, with respect tocatheter20.
• As should be readily apparent, the emission surface may comprise the surface of one or more ablative elements embedded thereon, such as one or more electrodes adapted to contact target tissue and emit thermally conductive ablative energy. Alternatively, one or more ablative elements may be encased within the ablation device itself, the catheter structure allowing a substantial portion of the ablative energy to pass therethrough and engage target tissue. Such a system has the additional advantage, especially when the material within which the ablative elements are encased absorbs substantially none of the ablative energy which passes therethrough, of not charring or adhering to the target tissue, or causing other tissue damage generally associated with thermal conduction based systems.[0037]
• The steering system of[0038]catheter20 typically comprises at least one pull wire operably attached to a control means as part of the handle portion (not shown) and thedistal portion24 at an attachment point A. Operation of the control means results in the deflection ofdistal portion24 ofcatheter20. Since the attachment point A is close to thedistal end26 ofdistal portion24 it is often difficult for an operator, an electrophysiologist for example, to manipulate thedistal portion24 in such a way as to position the emitting surface substantially proximal and parallel tocardiac tissue10 in order to create a desired lesion therein. As depicted in FIG. 1A, with an improperly positioned distal portion, a substantial portion of the ablative energy fails to effectively engagetissue10. Rather, the energy E₁is absorbed in the blood.
• As further depicted in FIG. 1A, when a portion of[0039]distal end26 engagestissue10, an approach angle α is defined between a longitudinal axis line L ofcatheter20 which passes through attachment point A and the surface oftissue10. Certain catheter systems may have distal energy delivery or ablation elements which are adapted to deliver an energy pattern from the distal end of the system toward a target tissue,distal end26 towardtissue10 for example, as depicted by arrows E₂. As should be readily understood, whencatheter20 is positioned as shown in FIG. 1A,distal end26 is not effectively placed perpendicularly in contact withtissue10. Thus, tip-firing energy E₂, like energy E₁, is not effectively transmitted totissue10, resulting in poor ablation formation therein. Therefore, when approach angle α is about 0°, energy E₁is most effectively transmitted totissue10. Conversely, when approach angle α is about 90°, energy E₁is most effectively transmitted totissue10.
• It is important to note that energy patterns E[0040]₁and E₂are generic in the sense that they do not depict energy patterns of ablation systems which require direct contact with the target tissue. However, as is discussed in more detail below, use of such systems is enhanced through the addition of structures and methods in accordance with the present invention. For example, ifdistal tip26 ofcatheter20 included an electrode which required direct contact withtarget tissue10, such a device would be difficult to maneuver and manipulate in such a way as to create numerous intermediate lesions as part of a long continuous lesion, especially during a beating heart procedure.
• Now turning also to FIG. 1B, a[0041]catheter100 in accordance with the present invention is shown. As depicted in FIG. 1A with respect tocatheter20,catheter100 is shown passing through theinferior vena cava14, thedistal end124 entering theright atrium16.Catheter100 comprises an elongatedtubular body member110 which leads to adistal portion124, and finally adistal end126.Distal portion124 comprises an ablation device130 (not shown) including one or more ablation elements136 (not shown) adapted to emit ablative energy therefrom toward a target tissue site.
• [0042]Catheter100 further incorporates asteering system102 having a distal attachment point A located proximal todistal portion124. As is discussed in greater detail below, oncedistal portion124 is within the right atrium, tension is applied to apull wire104 which acts to deflectportion124 substantially as shown. Therefore, as should be readily apparent from FIG. 1B, as thecatheter100 is deflected by steeringsystem102 from an initial position (shown in dashed line), with point A moving in a direction indicated by arrow D, the portion ofcatheter100 distally located from point A is directed toward at least a portion oftarget tissue10. Such a configuration enables thedistal portion124 ofcatheter100 to be placed proximal to targettissue10, allowing the emitted energy pattern E adjacent the point of contact to effectively impact upontarget tissue10, ensuring proper lesion formation at that location.
• As shown, when the[0043]distal portion124 engagestissue10, angle α₁is defined by the longitudinal axis line L₁ofcatheter100 which passes through attachment point A andtissue10. The overall flexibility ofdistal portion124 is sufficiently greater thantubular member110, such that translation ofpull wire104 results in the deflection ofportion124 with respect totubular member110, which substantially retains its form.
• Thus, it should be apparent that such a[0044]catheter system100 is much less dependent on the approach angle α for proper lesion formation adjacent the point of contact betweencatheter100 andtissue10, unlikecatheter20 discussed above. Moreover, thedistal portion124 can be preformed or deflected to take on a curvilinear shape allowing ablation systems which require direct contact with the target tissue to be more easily moved in a controlled manner about the surface of the target tissue. For example, if one or more electrodes are placed along thedistal portion124, one or more of the electrodes may be energized at any given time during movement ofdistal portion124 abouttissue10. Such a system offers better control and performance with respect to tip electrode systems which rely on moving the tip itself across the surface of the tissue.
• As will be discussed in more detail below,[0045]steering system102 may be incorporated into a separate guiding catheter (not shown), such that the ablation catheter, having an ablation device, can translate therein. It should also be noted that while the ablation device may be described as being deflected through operation ofpull wire104, this does not necessary mean the orientation of the ablation device is straight or linear. For example, the ablation device may be curved to address the natural curvature of an internal organ or to assist in its proper placement, the ablation device directed to the target tissue through the use of a guiding catheter configured to restrict the ablation device to an orientation similar to the guiding catheter until the ablation device emerges and assumes its predetermined form.
• The ablation device may also incorporate a shielding means adapted to be opaque with respect to the corresponding ablative energy utilized, protecting surrounding tissues from the ablative energy. Additionally, the shielding device may be adapted to reflect at least a portion of ablation energy toward the target tissue site.[0046]
• [0047]Steering system102 may be any suitable steering system able to properly deflectcatheter100 to achieve the desired ablations described herein. Such steering systems are disclosed in commonly owned and co-pending U.S. Patent Application entitled, “Catheter Having Improved Steering,” filed concurrently with the present application and hereby incorporated herein, in its entirety.
• Additionally, it should be noted that while the[0048]pull wire104 is shown traveling outside thecatheter100 structure, proximate todistal portion124, thedistal portion124 may comprise a lumen (not shown) ending near the distal tip through which thepull wire104 can translate. The lumen would be adapted to minimize frictional forces between itself and pullwire104 as well as provide attachment point DA at a distal end of the lumen neartip126. In this way, all components ofcatheter100 may be encased within the catheter itself.
• In operation,[0049]catheter100 is steered, or otherwise directed, through the operation ofsteering system102. Since thesteering system102 is operably attached at point SA alongcatheter100, thecatheter100 structure distal to point SA remains substantially unaffected by catheter steering. As is discussed in greater detail below, with reference momentarily to FIG. 4A, once thedistal portion124 is directed toward a target area within the patient, within the right atrium for example,distal portion124 is further deflected through operation ofpull wire104.
• Now turning to FIGS.[0050]2A-2E, the operation ofcatheter system100 can be more readily understood. While FIGS.2A-2E depict the ablation, or otherwise medical treatment, of the isthmus between the inferior vena cava (IVC)14 andtricuspid valve12, it should be apparent that such asystem100 can be utilized in other areas of the body or in association with other bodily organs, such as the bladder or stomach. As shown in FIG. 2A,catheter100 is depicted advancing percutaneously from a point proximal to theIVC14, the femoral vein for example, toward the target tissue site.
• Now referring specifically to FIG. 2B, as the[0051]distal portion124 ofcatheter100 enters theright atrium16, thesteering system102 acts to deflectdistal portion124 and directdistal tip126 in a direction generally toward thetricuspid valve12. As is depicted, and as should be readily understood, once thedistal portion124 is within the right atrium, thecatheter100 is typically no longer advanced, however,distal portion124 is continually deflected by operation of thesteering system102, as described in greater detail above. Continued operation of thesteering system102 results in further deflection ofdistal portion124 with respect to thecatheter member110, attachment point A moving generally in a direction noted by arrow M1.
• With reference also to FIG. 2C, once the[0052]distal portion124 lies within theatrium16, thedistal portion124 is deflected through translation of thepull wire104, as described in greater detail above. Once thedistal portion124 is deflected the desired predetermined amount, approximately 180° as shown for illustration purposes only, the distal portion is further directed towards target tissue through continued operation of steering means102, as depicted in FIG. 2D. Thedistal portion124 is steered, or otherwise further manipulated, until the a portion of thedistal portion124 is positioned proximate thetarget tissue10, indicated by position P1. As discussed above, irregardless of the approach angle α, with thedistal portion124 positioned as shown, ablative energy impinges upontarget tissue10 to create a first ablation and corresponding lesion at position P1.
• Once the first ablation is complete, further operation of steering means[0053]102 results in thedistal portion124 moving in a direction generally depicted as M2 alongtissue10 until a second position is reached, indicated by position P2 as shown in FIG. 2E. Additionally, once the ablation at position P2 is complete, thedistal portion124 is further advanced as described above until a position P3 is reached.
• Now with reference to FIGS.[0054]3A-3C, another embodiment of an exemplary catheter system will be discussed. As depicted,catheter system200 comprises a guidingcatheter201 having at least one lumen passing therethrough, and a steering system202 operably attaching to guidingcatheter201 generally at the attachment point SA.Catheter system200 further comprises anablation catheter204 which translates through the at least one lumen of the guidingcatheter201.Ablation catheter204 comprises a deflection means for deflecting thedistal portion224 thereof. The deflection means may be any suitable means, such as the deflection means described above with reference tocatheter system100.
• Preferably, the deflection means comprises a preformed or[0055]preshaped support member250 encased within a portion ofdistal portion224.Member250, when no external forces are acting upondistal portion224, acts to deflectdistal portion224 to its preformed or preshaped orientation. The flexibility ofmember250 is somewhat less than that of guidingcatheter201, such that as thedistal portion224 exits the distal opening ofcatheter201,distal portion224 takes on the preformed shape ofmember250, as is discussed in more detail below.Support member250 may be formed having any suitable cross-sectional geometry including, but not limited to, circular, square, elliptical, or rectangular. For example, the cross-sectional geometry may be in the form of a rectangle limiting its deflection to the geometric plane passing through the longitudinal axis of theablation catheter204 during deflection ofdistal portion224. In this way thedistal portion224 may be more precisely placed upon target tissue.
• As with[0056]catheter system100 discussed above, operation ofcatheter system200 requires introduction of the catheter system into a patient's body, through the vasculature for example, and advanced until a distal portion is proximate target tissue to be ablated. Once the distal portion is in place, thecatheter system200 can be further manipulated to allow for ablation of the target tissue and formation of one or more desired lesions.
• As shown in FIG. 3A, guiding[0057]catheter201 ofcatheter system200 is entered into the patient's vasculature, proximate to the femoral vein for example, and advanced into theIVC14 until a distal portion203 ofcatheter201 is within theright atrium16, substantially as shown. Once the guidingcatheter201 is properly placed, theablation catheter204 is translated through the at least one lumen ofcatheter201 in a direction indicated by arrow M until a distal end ofcatheter204 is positioned adjacent the distal opening of guidingcatheter201, as generally depicted by FIG. 3A.
• With reference also to FIG. 3B, once the guiding[0058]catheter201 is properly positioned, theablation catheter204 is further advanced by operation of the advancement means by the user allowing thedistal portion224 to exit the distal opening of the guidingcatheter201. As depicted specifically in FIG. 3B, as thedistal portion204exits guiding catheter201, thesupport member250 acts to deflect thedistal portion204 into a predetermined shape, as discussed above. With reference also to FIG. 3C, as theablation catheter204 is further advanced, thedistal portion224 further takes on the predetermined shape ofsupport member250 until the final shape is achieved. For illustrative purposes only, FIG. 3C depicts thedistal portion224 ofablation catheter204 in a semi-circular shape. It should be apparent that other shapes can be selected, these shapes being directly based on the target tissue selected.
• Once the[0059]distal portion224 takes on its desired predetermined shape, theablation catheter204 is further advanced until at least a portion ofdistal portion224 engages or is otherwise proximate to the target tissue. An exemplary position is shown in dashed line in FIG. 3C,distal portion224 engagestarget tissue10 generally at the position indicated by P1. Thesteering system201 of guidingcatheter201 is further manipulated by the User to further movedistal portion224 acrosstarget tissue10, creating intermediate lesions as part of a desired lesion path as further discussed above with respect tocatheter system100.
• Now turning to FIGS. 4A and 4B, an[0060]exemplary catheter system100A having a deflectable distal portion in accordance with the present invention will be discussed in greater detail. As stated above with respect tocatheter100, generallycatheter100A comprises elongatedtubular member110 having at least one lumen passing therethrough. Thetubular member110 ends indistal portion124. As shown,distal portion124 includesablation device130 comprisingablation element136.
• In the embodiment of FIGS. 4A and 4B,[0061]ablation element136 is a flexible antenna encased in an insulatingmaterial134 adapted to emit electromagnetic energy radially about its structure over substantially its entire length, a portion of the radiated energy pattern generally depicted by arrowsE. Insulating material134 acts to hold ablation element132 a fixed distance from the target tissue,tissue10 for example, when thedistal portion124 contacts the tissue as depicted in FIGS. 2A and 2B. For the ablation device depicted, the insulator is a low-loss dielectric material able to transmit a substantial portion of ablative energy therethrough. Such materials may include, but are not limited to, TEFLON®, silicone, polyethylene, polyimide, or other materials having similar properties.
• [0062]Ablation element136 is coupled to a transmission medium adapted for transmission of ablative energy from an energy source, a microwave generator for example. The transmission medium may comprise, for illustration purposes only, a center conductor which is electrically coupled to a proximal end ofablation element136, an outer conductor and an insulating material therebetween. For example, the transmission medium may be a coaxial cable adapted to transmit energy therethrough toablation element136 at predetermined power levels sufficient for ablating the target tissue. Additionally, for illustration purposes only, other exemplar modalities may include one or more optical fibers as part of a laser ablation system, metallic wires or coaxial cable for an ultrasound or RF ablation system, and tubular members having passages therethrough for fluid or gas agents utilized by cryogenic ablation systems.
• It should be noted that the efficiency of[0063]ablation device130 is related to, among other things, the ability of the transmission medium to effectively transmit energy from the energy source toablation element136. Therefore,ablation device130 may further comprise elements which maximize the efficiency of the ablation system. For example, these elements may comprises one or more passive components which interface to one or more elements of the ablation system, comprising the energy source, transmission medium and ablation device, acting to match the impedance characteristics of, or otherwise tune, the ablation system itself.
• While[0064]ablation element136 is depicted as a linear antenna structure, any suitable structure can be used including, but not limited to, a helical antenna, an isolated monopole antenna, a lossy transmission line, or an exposed monopole antenna. Theablation element136 can be formed from any suitable material including, but not limited to, spring steel, beryllium copper, or silver-plated copper. The diameter ofelement136 may be from about 0.005 to about 0.030 inches, and more preferably from about 0.013 to about 0.020 inches.
• As shown,[0065]catheter100A also includespull wire104 which has distal and proximal ends, the distal end operably attached to the handle portion (not shown) and the proximal end fixedly attached to thecatheter100A at or near adistal tip126, designated as attachment point DA. Thepull wire104 exits thetubular member110 at or near thedistal portion124 throughopening106 and travels along the exterior ofmember110 to the attachment point DA, as discussed immediately above.
• While FIGS. 4 and 5 depict[0066]pull wire104 loosely placed withincatheter100, it should be apparent that pullwire104 could be enclosed within a separate tubular member104A (not shown). Member104A would preferably run the length ofcatheter100, the proximal end fixedly attached to the handle portion (not shown) and the distal end fixedly attached tocatheter100 structure. Alternatively, member104A could be part of theouter catheter100 structure, fixedly attached to and integral to the structure along the entire length ofcatheter100. In this way, deflection forces associated withdistal portion124 can be transmitted directly to the handle portion, preventing undesirable deflection ofcatheter100 and any tissue damage related thereto.
• [0067]Distal portion124 may optionally comprise aflexible support member150.Support member150 runs substantially the length ofdistal portion124, with a proximal end ofmember150 fixedly attached tocatheter100.Support member150 preferably has a rectangular cross-section encouraging deflecting of thedistal portion124 along one plane.Support member150 also acts to define a minimum radius of curvature to ensure consistent deflection ofdistal portion124 along its length.
• With reference now to FIGS. 5A and 5B, another[0068]catheter system100B shall be discussed. As depicted, thecatheter system100B is similar tosystem100A except fordistal portion124.Distal portion124 ofcatheter100B further comprises a shielding means152 adapted to shield surrounding tissue from ablative energy emitted therefrom. As discussed above, shielding means152 may act to absorb ablative energy, microwave energy in this specific case, or reflect and redirect the ablative energy toward the target tissue to enhance ablation, reflection of the energy being a function of the construction material of shielding means152 and redirection of the energy being a function of the geometric shape of shielding means152. To facilitate absorption of the microwave energy, shielding means152 may be formed from any suitable microwave absorption material with high loss tangent, such as a polymer filled with metallic powder for example. The geometric structure of shielding means152 may define the resulting energy reflections to more precisely direct ablative energy toward target tissue.
• With reference to FIGS. 5A and 5B, shielding means[0069]152 acts to reflect at least a portion of the energy emitted byablation element136 toward target tissue,tissue10 for example, resulting in more efficient ablation of the tissue. Furthermore, while shielding means152 is shown having a curvilinear geometric shape, shielding means152 may also be substantially planar in construction, formed from metallic foil for example. Alternatively, shielding means152 may be constructed from a metallic wire mesh of copper, the wire mesh having wire spacing sufficient to prohibit passage of electromagnetic energy therethrough.
• With reference now to FIGS. 6A and 6B,[0070]catheter systems100 havingdiffering ablation devices130 will be discussed. With specific reference to FIG. 6A, acatheter100B is depicted havingdistal portion124 comprisingablation device130 similar to that depicted in FIGS. 5A and 5B. As shown,distal portion124 is deflected to a first position through translation ofpull wire104. Once deflected, theablation device130 ofcatheter100B emits an ablative energy pattern as depicted by area E₁. It should be understood, as with other depictions described herein, the energy pattern E₁may be depicted in a planar view, such as in FIG. 6A, however, the ablative energy emitted has three-dimensional characteristics.
• As discussed above, with the[0071]distal portion124 deflected and the ablation device emitting energy as depicted by pattern E₁, the angle of approach α ofcatheter100B becomes less significant. As described above, the longitudinal axis L ofcatheter member110, which passes through attachment point A generally defines an attack angle α with respect to the target tissue,tissue10 for example.
• This advantage is more clearly understood when considering the distal portion engaging tissue[0072]10A, the surface of tissue10A shown in dashed line. Here, the approach angle α_A, as defined in a similar fashion as immediately above. As depicted by the representative ablative energy pattern E₁, an equivalent amount of ablative energy is directed toward thetarget tissue10,10A, irregardless of the approach angle α, α_A, such that a desire ablation of the target tissue is performed. As clearly shown in FIG. 6A, ablation oftissue10 is not directly dependent on the approach angle α, α_A.
• Further translation of[0073]pull wire104 results in further deflection ofdistal portion124 to a second position shown in dashed line. With thedistal portion124 deflected to the second position a corresponding energy pattern E₂is produced. The first and second position are exemplary positions depicting energy dispersion from between approximately 180° to about 270°. It should be understood, however, that energy dispersion ranges could vary from approximately 0° to about 270° with reference to the proximal end ofportion124, depending on the needs of the user, a surgeon for example. Additionally, it should be noted that while theablation device130 has been described as having a substantially circular configuration, other configurations are contemplated within the scope of the present invention to allow the User to ablate tissues of differing geometries.
• While the[0074]ablation device130 of thecatheter100B embodiment comprisessupport member150, theshielding device152 may be adapted to control the geometry of deflection with respect to thedistal portion124. Additionally, as stated above, the shielding means152 may be configured such that the flexibility changes along its longitudinal axis resulting in different geometric configurations whendistal portion124 is deflected.
• Now turning to FIG. 6B, another[0075]catheter100 incorporating an alternative ablation device is shown.Catheter100C has adistal portion124 including an ablation device comprising at least one radio frequency (RF) electrode136A-E operably controlled by the User through controlling means140. Theelectrodes136A-E ofablation device130 define an energy pattern depicted by E, shown in dashed line. Controlling means140 controls the application of energy to theelectrodes136A-E, either alone, as a group of one or more, or the entire group. For example, controlling means140 ofcatheter100C may comprise one or more electrically conductive wires operably connected toelectrodes136A-E and the handle portion (not shown). The User would apply ablative energy to target tissue through the direction of energy through one ormore electrodes136A-E via controllingmeans140.
• It is important to note that the depiction of energy dispersions discussed herein do not take into account the efficiency of the different modalities disclosed herein. The energy patterns described herein are for discussion purposed only. It should be clear from the discussion herein that the energy emitted from the ablation element(s) will impact target tissue in an equivalent manner, without respect to an approach angle α as defined herein.[0076]
• Note that the[0077]ablation device130 ofdistal portion124 ofcatheter100C, may comprise more or less RF electrodes further defining an appropriate energy pattern E. Furthermore, theRF electrodes136A-E may be in the form of a coiled spring such that the RF electrodes themselves may individually deflect as thedistal portion124 deflects. While the RF electrodes are shown in a spaced-apart relationship with respect to each other,electrodes136A-E may be positioned in close proximity with respect to each other, further defining energy dispersion. Additionally, eachRF electrode136A-E may be controlled separately through control means140, further controlling or defining the energy dispersion area. Theelectrodes136A-E may be semi-circular defining an energy pattern which is directed 180° about the longitudinal axis of the device, essentially defining a side-firing device which, when the distal portion is deflected, can transform partially or totally into a distal firing device.
• While the above procedure is described in terms of three lesions, the actual number of overlapping lesions is a function of the ablative energy utilized and the configuration of[0078]distal portion124, comprisingablative device130. For example, the length of any intermediate lesion created is a direct function of the dimensional characteristics of the ablation device utilized. Therefore, the desired resultant long continuous lesion may comprise the creation of fewer or greater intermediate lesions than described above.
• As discussed in more detail above,[0079]ablation device130 may also include an energy shielding means adapted to be opaque to the ablative energy utilized, such that, tissue adjacent to targettissue10, for example, is protected from the ablative energy. Furthermore, is should be noted that the energy shielding means can be further adapted to reflect the ablative energy in a predetermined and desirable fashion as to focus the ablative energy at a desired region of thetarget tissue10, whereby the lesion characteristics can be better controlled.
• For example, considering the ablative element of FIGS. 5A & 5B, the shielding means may be formed to reflect and direct microwave energy in a relatively thin line along the longitudinal axis of the antenna, resulting in the desired formation of a relatively thin long intermediate lesion. Alternatively, the shielding means of a cryo based system may be constructed from thermal isolating material, the shielding means[0080]152 axially surrounding a substantial portion ofablative device130 leaving only a relatively thin opening along the longitudinal axis ofdevice130, corresponding to a desired lesion. The opening would be controllably directed towardtarget tissue10, as discussed above, to create an intermediate lesion. Additionally,steering system102 may be constructed as to limit the deflection of intermediate portion118 to one plane, ensuring, for example, that the opening of the cryo-basedablation device130, discussed immediately above, is directed towardtarget tissue10.
• While the[0081]ablative device130 is preferably adapted to emit microwave energy sufficient to ablate the target tissue upon which a lesion is desired, other ablative energies utilized by anablative device130 incatheter100 may include, but is not limited to, one or more of the following energies, along or in combination: microwave energy, laser energy or other forms of light energy in both the visible and nonvisible range, radio frequency (RF) energy, ultrasonic energy, cryogenic energy, chemical agent, thermal energy, or any other energy which can be controllably emitted and directed at least towards a portion of a desired target tissue, transporting ablation energy to the target tissue at sufficient energy levels resulting in tissue ablation and corresponding lesion formation.
• One[0082]exemplary ablation device130 comprises a monopole microwave antenna as disclosed and further described in commonly owned U.S. Pat. No. 6,277,113, entitled “Monopole Tip for Ablation Catheter and Methods for Using Same,” which is hereby incorporated herein by reference, in its entirety. Alternatively,ablation device130 may comprise other microwave antenna structures as disclosed and further described in commonly owned U.S. Pat. No. 6,245,062, entitled “Directional Reflector Shield Assembly for a Microwave Ablation Instrument,” U.S. patent application Ser. No. 09/484,548, filed Jan. 18, 2000, entitled “Microwave Ablation Instrument With Flexible Antenna Assembly and Method”, and U.S. patent application Ser. No. 09/751,472, filed Dec. 28, 2000, entitled “A Tissue Ablation Apparatus with a Sliding Ablation Instrument and Method,” all hereby incorporated herein by reference, each in its entirety.
• Additionally,[0083]catheter100 may further comprise one or more electrodes strategically placed upon thedistal portion124 to facilitate capture of certain electrophysiological signals. Such signals allow a User to determine tissue characteristics of a target tissue site and also provide confirmation that thedistal portion124 is properly positioned substantially proximal and parallel to a target tissue, for example. Such electrode arrangement systems may be similar to those disclosed in U.S. patent application Ser. No. 09/548,331, filed Apr. 12, 2000, entitled “Electrode Arrangement for Use in A Medical Instrument,” hereby incorporated herein by reference, in its entirety.
• While the present invention has been primarily described with respect to tissue ablations within the right atrium of the heart, it will be appreciated that the ablation systems disclosed herein may just as easily be applied to ablation of other tissues, such as the tissue surrounding the sinus cavities for example. The tissue ablations may be performed through either open surgery techniques or through minimal invasive techniques.[0084]
• Although the foregoing invention has been described in some detail for purposes of clarity of understanding, it will be apparent that certain changes and modifications may be practiced within the scope of the appended claims.[0085]

Claims (52)

What is claimed is:

1. A flexible ablation system for ablation of biological tissue at a target tissue site, comprising:

a handle portion;

a tubular member having proximal and distal portions and a longitudinal axis which, at a point just proximal to the distal portion, defines an azimuth angle with respect to the target tissue, the handle portion operably attached to the proximal portion of the tubular member;

at least one ablation element operably disposed at the distal portion of the tubular member, the at least one ablation element adapted to emit ablative energy; and

a means for deflecting the distal portion of the tubular member,

wherein the distal portion of the tubular member is configured to be deflected to a predetermined shape wherefrom a desired energy pattern is emitted which is substantially independent of the azimuth angle.

2. The system ofclaim 1 further comprising a means for directionally controlling ablative energy emitted from the at least one ablation element.

3. The system ofclaim 2, wherein the means for directionally controlling ablative energy is flexible, whereby the directionally controlling means deflects as the distal portion of the tubular member is deflected.

4. The system ofclaim 3, wherein the means for directionally controlling the ablative energy allows for the emission of energy in a radial pattern, substantially 180 degrees about the longitudinal axis of the distal portion.

5. The system ofclaim 4, wherein the means for directionally controlling the ablative energy comprises a shield device adapted to be opaque to at least a portion of the ablative energy emitted, whereby a portion of biological tissue adjacent to the distal portion of the ablation system is shielded from the ablation energy.

6. The system ofclaim 5, wherein the shield member reflects at least a portion of the ablative energy in a direction toward the target tissue site.

7. The system ofclaim 6, wherein the geometric surface of the shield member along a longitudinal axis is substantially planar.

8. The system ofclaim 6, wherein the geometric surface of the shield member along a longitudinal axis comprises at least one curved portion corresponding to a desired ablation pattern.

9. The system ofclaim 8, wherein the shield member is substantially convex with respect to the longitudinal axis of the ablation system, the ablative energy being longitudinally dispersed across a target tissue site.

10. The system ofclaim 8, wherein the shield member is substantially concave with respect to the longitudinal axis of the ablation system, the ablative energy being longitudinally focused upon a target tissue site.

11. The system ofclaim 1, wherein the at least one ablation element is flexible, whereby the at least one ablation element deflects as the distal portion of the tubular member is deflected.

12. The system ofclaim 11, wherein the at least one ablation element is an antenna adapted to emit electromagnetic energy.

13. The system ofclaim 12, wherein the antenna is one selected from the group consisting of: a linear antenna, a helical antenna, a monopole antenna, and a lossy transmission line.

14. The system ofclaim 11, wherein the at least one ablation element is an electrode having the form of a helical spring.

15. The system ofclaim 1, wherein the ablative energy is one or more energies selected from the group consisting of: microwave, laser or other forms of light energy in both the visible and non-visible range, radio frequency (RF), ultrasonic, cryogenic, thermal, and chemical.

16. The system ofclaim 1, wherein the deflection means comprises at least one pull wire operably attached to a distal end of the distal portion of the tubular member and the handle portion.

17. The system ofclaim 16, wherein the distal portion of the tubular member is generally linear, translation of the at least one pull wire results in deflection of the distal portion between a linear configuration and a deflected configuration.

17. The system ofclaim 16, wherein the distal portion of the tubular member is preformed, translation of the at least one pull wire results in deflection of the distal portion between a preformed configuration and a linear configuration.

18. The system ofclaim 1, wherein the predetermined shape is curvilinear.

19. The system ofclaim 1, wherein the predetermined shape is substantially circular.

20. The system ofclaim 19, wherein the predetermined shape has a radius of from about 0.5 cm. to about 5 cm.

21. The system ofclaim 15, further comprising a means for steering the distal portion of the tubular member, the steering means operably attached to the tubular member and the handle portion,

wherein operation of the steering means effects a change in the azimuth angle.

23. The system ofclaim 16 further comprising a guiding member having at least one lumen passing therethrough and including a means for steering the distal portion of the tubular member, the tubular member translatably disposed within a first of the at least one lumen,

wherein operation of the steering means effects a change in the azimuth angle while the tubular member is free to translate within the guiding member.

24. The system ofclaim 23, wherein the distal portion of the tubular member is preformed having a curvature of a predetermined radius,

whereby the distal portion of the tubular member assumes its preformed curvilinear shape as the tubular member translates out the distal opening of the guiding member.

25. The system ofclaim 24, wherein the predetermined radius is from about 1 cm. to about 5 cm.

26. The system ofclaim 23, wherein the deflection means comprises a springy member which acts to manipulate the distal portion of the elongated tubular member to the predetermined shape in response to a change in external forces acting thereupon.

27. The system ofclaim 26, wherein the springy member is a superelastic material.

28. The system ofclaim 18, wherein the distal portion of the tubular member further comprises at least one prebend of a predetermined angle located proximal to the at least one ablation element,

whereby the prebend cooperates with the distal opening of the guiding member and further deflects the distal portion of the tubular member as the tubular member translates out the distal opening of the guiding member.

29. A method of ablating tissue, comprising the steps of:

providing an ablation system comprising a tubular member having a deflectable distal portion, the distal portion comprising at least one ablation element from which ablative energy is emitted, the distal portion being configured to be deflected to a predetermined shape wherefrom a relatively uniform energy pattern is emitted;

advancing the distal portion of the ablation system into a patient's body until the distal portion is near a target tissue site;

deflecting the distal portion of the ablation catheter, the distal portion assuming the predetermined shape;

advancing the distal portion of the ablation catheter until the distal portion is proximate the target tissue; and

applying ablative energy to the at least one ablation element to ablate the target tissue proximate the distal portion of the ablation catheter.

30. The method ofclaim 29, wherein the ablation of the target tissue results in the formation of at least one lesion as part of a desired lesion path.

31. The method ofclaim 29, wherein the ablation catheter further comprises a steering means operably attached to the ablation catheter proximal to the distal portion thereof and the method further comprises the step of operating the steering means such that the distal portion of the ablation catheter is moved from a first position to a second position.

32. The method ofclaim 31, wherein the first position and the second position overlap and the step of ablating results in the creation of a long continuous deep lesion corresponding to the first and second position.

33. A method for ablating a target tissue within a hollow body organ, the steps comprising:

providing an elongated tubular member having a means for deflecting a distal end thereof, the distal end including at least one ablation element, wherein operation of the deflection means results in the creation of a desired energy pattern about the distal end of the elongated tubular member;

advancing the distal end of the tubular member to a point where at least a portion of the distal end is within the hollow body organ;

operating the deflection means to deflect at least a portion of the distal end of the tubular member;

positioning at least a portion of the distal end of the tubular member proximate to the target tissue, the longitudinal axis of the tubular member immediately proximal to the distal portion thereof and the target tissue defining an azimuth angle therebetween;

ablating at least a portion of the target tissue.

34. The method ofclaim 33, wherein the step of advancing the distal end comprises the step of advancing the distal end of the tubular member until the distal portion thereof is within the hollow body organ.

35. The method ofclaim 33, wherein the step of operating the deflection means results in the creation of a uniform energy pattern about the distal portion of the elongated tubular member such that the step of ablating occurs without respect to the azimuth angle.

36. The method ofclaim 33, wherein the azimuth angle is from about 0° to about 180°.

37. The method ofclaim 33, wherein the elongated tubular member further comprises a steering means and the step of positioning comprises the step of positioning at one of a plurality of positions.

38. The method ofclaim 37, wherein the plurality of positions define a continuous ablation path.

39. The method ofclaim 38, wherein the step of ablating results in the formation of a long continuous deep lesion along the ablation path.

40. An ablation system for ablating a hollow body organ, comprising:

an elongated tubular member having a means for deflecting a distal portion thereof, the longitudinal axis of the tubular member immediately proximal to the distal portion and the surface of a target tissue defining an angle therebetween; and

an ablation device operably disposed at the distal end of the elongated tubular member and including at least one ablation element adapted to emit ablative energy therefrom,

wherein operation of the deflection means results in the creation of a uniform energy pattern about the distal portion of the tubular member, whereby ablation of a portion of the target tissue occurs independent of the angle.

41. The system ofclaim 40 wherein deflection means comprises at least one pull wire having a distal end fixedly attached to the distal portion.

42. The system ofclaim 41, wherein the at least a portion of the at least one pull wire is operably located external and adjacent to the distal portion.

43. The system ofclaim 40, wherein the at least one ablation element is an antenna adapted to emit electromagnetic energy therefrom.

44. The system ofclaim 40, wherein the at least one ablation element is an electrode.

45. The system ofclaim 40, wherein the ablative energy is one or more energies selected from the group consisting of microwave, laser or other forms of light energy in both the visible and non-visible range, radio frequency (RF), ultrasonic, cryogenic, thermal, and chemical.

46. A flexible ablation system, comprising:

a tubular member having proximal and distal portions and a longitudinal axis which, at a point just proximal to the distal portion, defines an azimuth angle with respect to the target tissue; and

at least one ablation element operably disposed at the distal portion of the tubular member, the at least one ablation element adapted to emit ablative energy; and

a means for shaping the distal portion of the tubular member,

wherein a desired energy pattern is emitted from the shaped distal portion, the energy pattern engaging a target tissue independent of the azimuth angle.

47. The system ofclaim 46, wherein the at least one ablation element is configured to emit ablative energy substantially perpendicular to the longitudinal axis of the tubular member.

48. An ablation system for ablating biological tissue, comprising:

a tubular member having a distal portion and a longitudinal axis;

at least one ablation element operably disposed at the distal portion of the tubular member and adapted to emit ablative energy in a substantially lateral direction along the longitudinal axis of the tubular member; and

a means for deflecting at least the distal portion of the tubular member,

wherein upon deflection of at least a portion of the distal portion of the tubular member, a relatively uniform energy distribution is formed about the deflected portion.

49. The system ofclaim 48, wherein the deflected portion is shaped to follow the natural contour of the biological tissue.

50. The system ofclaim 49, wherein the surface of the biological tissue is concave.

51. The system ofclaim 48, wherein the at least one ablation element is adapted to emit unidirectional ablative energy.

52. The system ofclaim 49, wherein the biological tissue is the isthmus between the inferior vena cava and the tricuspid valve.

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